PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

K101869 · Silmet , Ltd. · EMA · Sep 29, 2010 · Dental

Device Facts

• Record ID: K101869
• Device Name: PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
• Applicant: Silmet , Ltd.
• Product Code: EMA · Dental
• Decision Date: Sep 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Device Story

ProGlass Cements are glass ionomer dental materials used for restorative, luting, and base/liner applications. The device consists of a powder component (fluoroaluminosilicate glass) and a liquid component (polyacrylic acid, water, tartaric acid, or monomers like HEMA/TMHMD depending on the specific product). The clinician mixes the powder and liquid to initiate an acid-base reaction, creating a set cement. Used in dental clinics by dentists to affix crowns, bridges, and orthodontic appliances, or to restore tooth structure. The material provides a physical barrier and adhesive bond to tooth structure. Benefits include tooth protection, structural support for restorations, and stabilization of dental devices. No electronic or software components are involved.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence is established through comparison of material composition, physical characteristics (mixing time, working time, setting time), and intended use to legally marketed predicate devices.

Technological Characteristics

Glass ionomer cements composed of fluoroaluminosilicate (FAS) glass powder and polyacrylic acid liquid. Some variants include HEMA, TMHMD, or silver. Setting mechanism is a chemical acid-base reaction; ProGlass Two LC requires light curing (20 seconds). Form factor is a two-part powder/liquid system. No electronic components, software, or connectivity.

Indications for Use

Indicated for dental restoration, luting, and base/liner applications. ProGlass One: luting metal/porcelain/resin crowns, inlays, onlays, bridges, orthodontic bands, stainless steel crowns; base/liner. ProGlass Two: Class III, V, limited Class I cavities, primary teeth restoration, core build-up. ProGlass Two LC: Class III, V restorations, cervical erosions, root surface caries, core build-up, base/liner. ProGlass Nine: Class I, II cavities, primary teeth, long-term non-load bearing restoration, intermediate restorative, sandwich material, core build-up. ProGlass Plus: metal-based/ceramic/reinforced ceramic/acrylic/resin restorations. ProGlass Silver: Class I, limited Class II, temporary fillings, primary teeth, core build-up, base/liner. Contraindicated for pulp capping.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Fuji I (K980695, GC America)
• Fuji II (K980682, GC America)
• Fuji II LC (K961584, GC America)
• Fuji IX (K961448, GC America)
• Fuji Duet (Fuji Plus) (K946100, GC America)
• Miracle Mix (K984505, GC America)

Submission Summary (Full Text)

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# K101869

# SEP 2 9 2010

# 5. 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of 21 C.F.R. part 872.3275

## Date prepared: June 29, 2010

# Company

| Name | Silmet Ltd |
|-----------|-------------------------------------------------------------|
| Address | 12 Hassadna St., Industrial Park<br>Or Yehuda 60200. Israel |
| Telephone | 972 3 5331474 |
| Fax | 972 3 5331581 |
| Contact | Moshe Zalsman |
| e-mail | [e-mail] |

## Devices

Trade Name:

ProGlass Cements (ProGlass One, ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver)

| Classification Name: | Cement, Dental (872.3275) |
|----------------------|---------------------------|
| Common Name: | Glass lonomer Cements |
| Regulatory class: | Class II |

### Predicate Devices

| Fuji I | (K980695, GC America) |
|-----------------------|-----------------------|
| Fuji II | (K980682, GC America) |
| Fuji II LC | (K961584, GC America) |
| Fuji IX | (K961448, GC America) |
| Fuji Duet (Fuji Plus) | (K946100, GC America) |
| Miracle Mix | (K984505, GC America) |

# Description

The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

# Device function, scientific concept, physical and performance characteristics

Glass Ionomer Cements are based on the reaction of silicate glass powder and polyalkeonic acid (acid - base reation) and have the following essential components:

- · an ionic polymer which is a polycarboxylic acid
- · a fluoroaluminosilcate (FAS) glass powder

- · water
· tartaric acid.

The above components are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide a set cement.

File No, 62010 PG 510k – FDA

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# General Applications

- . Luting crowns, bridges and orthodontic brackets
- Restorative cements .
- Lining cements, Base. .

Table 1: Device characteristics

| | Function | Components | |
|-----------------|--------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | | Powder | Liquid |
| ProGlass One | Luting Cement | Alumino-silicate glass<br>Polyacrylic acid | Distilled water<br>Polyacrylic acid |
| ProGlass Two | Restorative | Alumino-silicate glass<br>Polyacrylic acid | Distilled water<br>Polyacrylic acid |
| ProGlass Two LC | Reinforced Restorative<br>Base/Liner | Alumino-silicate glass | Distilled water<br>Polyacrylic acid<br>2-hydroxyethyl methacrylate (HEMA)<br>2,2,4, Trimethyl hexamethylene<br>dicarbonate (TMHMD) |
| ProGlass Nine | Restorative<br>Base/Liner | Alumino-silicate glass<br>Polyacrylic acid | Polyacrylic acid<br>Tartaric acid<br>Distilled water |
| ProGlass Plus | Luting Cement | Alumino-silicate glass | Distilled water<br>Polyacrylic acid<br>2-Hydroxyethylmethacrylate<br>Urethanedimethacrylate |
| ProGlass Silver | Restorative | Alumino-silicate glass<br>Silver | Polyacrylic acid |

Table 2: Physical characteristics

| | ProGlass<br>One | ProGlass<br>Two | ProGlass<br>Two LC | ProGlass<br>Nine | ProGlass<br>Plus | ProGlass<br>Silver |
|------------------------|-----------------|-----------------|--------------------|------------------|------------------|--------------------|
| Powder /liquid | 2.4 / 1.0 | 3.5 / 1.0 | 2.3 /1.0 | 4.1 / 1.0 | 1.5 / 1.0 | 4.0 / 1.0 |
| Mixing time (sec) | 30" | 30" | 30" | 30" | 30" | 20" |
| Working time | 2' 30" - 3' | 1' 30" - 2' | 3' | 2' 30" | 3' | 1'40" |
| Setting Time (min.sec) | 3'10" - | 3' 10" - 3' | 3' - | 3' 30" | 3' | 4' |
| Light Cure (sec) | | | 20" | | | |

File No. 62010 PG 510k – FDA

ﻜﺮ

SILMET LTD. 12 Hassalna St. Industrial Park. Or Yebuda 6020 Israel. Tel: [phone] Fisc [phone] | e-mail:[e-mail]

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# Indications for use

| Products | Indications for Use |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ProGlass One | Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays,<br>onlays & bridges<br>Cementation of orthodontic bands<br>Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns<br>Base/liner |
| ProGlass Two | Class III, V and limited class I cavities<br>Restoration of primary teeth<br>Core Build Up |
| ProGlass Two LC | Class III and V restorations<br>Restoration of Cervical erosions and root surface caries<br>Core Build Up<br>Base/Liner |
| ProGlass Nine | Class I & II cavities<br>Decidious teeth: final restorative for Class I, II and V<br>Long term restorative in non-load bearing areas of Class I, II and V<br>Intermediate restorative & sandwich material for heavy stress bearing<br>Core build up material |
| ProGlass Plus | Metal-based restorations<br>Ceramic inlays<br>Reinforced ceramic crowns and bridges<br>All kinds of acrylic/resin crowns, inlays, onlays and bridges |
| ProGlass Silver | Class I, limited Class II, temporary fillings<br>Restoration of primary teeth<br>Core Build Up<br>Base/Liner |

# Contraindications: Pulp capping

# Technological characteristics

All of the components of ProGlass Cements are found in the legally marketed devices:

Fuji I (K980695, GC America), Fuji II (K980682, GC America), Fuji II LC (K961584, GC America), Fuji IX (K961448, GC America), Fuji Plus (K946100 , GC Ameriea) , Miracle Mix (K984505, GC America)

The material, design and use concept is similar.

The prior use of all the components in the legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional bio-compatibility studies with the final formulation are not necessary.

We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of ProGlass Cements for the intended use.

# Conclusion

In accordance with 21 C.F.R. part 872.3275 and FDA's " Guidance for the preparation of Premarket Notifications for Dental Cements" and based on the information provided in this premarket notification, Silmet Ltd. concludes that ProGlass Cements are safe and effective and substantially equivalent to the predicate devices described herein.

29 June 2010 SILMET LTD.

CEO: Moshe Zalsman

13

Signature:

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File No. 62010 PG S10k – FDA

.. ..

STLMET LTD. 12 Hussadia St. Industrial Park. Or Yebula 60200 kssel. Tel: [phone] | e-mail:[e-mail]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Sharon Chaplik SILMET, Limited 12 Hasadna or Yehuda Israel 60200

SEP 2 9 2010

Re: K101869

Trade/Device Name: ProGlass Cements (ProGlass One, ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 29, 2010 Received: July 2, 2010

Dear Ms. Chaplik:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2- Ms. Chaplik

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

SEP 2 9 2010

2101869 510(k) Number (if known):

Device Name: ProGlass Cements ( ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver)

| Products | Indications for Use |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ProGlass One | Cementation of all types of metal, porcelain fused to metal, resin<br>crowns, inlays, onlays & bridges<br>Cementation of orthodontic bands<br>Cementation of stainless steel crowns or orthodontic appliances<br>retained with stainless steel crowns<br>Base/liner |
| ProGlass Two | Class III, V and limited class I cavities<br>Restoration of primary teeth<br>Core Build Up |
| ProGlass Two LC | Class III and V restorations<br>Restoration of Cervical erosions and root surface caries<br>Core Build Up<br>Base/Liner |
| ProGlass Nine | Class I & II cavities<br>Decidious teeth: final restorative for Class I, II and V<br>Long term restorative in non-load bearing areas of Class I, II and V<br>Intermediate restorative & sandwich material for heavy stress bearing<br>Core build up material |
| ProGlass Plus | Metal-based restorations<br>Ceramic inlays<br>Reinforced ceramic crowns and bridges<br>All kinds of acrylic/resin crowns, inlays, onlays and bridges |
| ProGlass Silver | Class I, limited Class II, temporary fillings<br>Restoration of primary teeth<br>Core Build Up<br>Base/Liner |

Prescription Use __ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| File No. 62010 PG 510k - FDA | |
|------------------------------|--|
|------------------------------|--|

Concurrence of CDRH, Office of Device (Division Sign-Off ODE)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices Page ___ of ___

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|----------------|---------|
| 510(k) Number: | K101869 |

SILMET LTD. 12 Hassadna St. Industrial Park. Or Yehuda 60200 Israel. Tel: [phone] Fax: [phone] e-mail:[e-mail] www.silmetdental.com